CAB+RPV LA for HIV

(IM-CAPABLE Trial)

Recruiting at 1 trial location

Overseen By Jennifer O'Neill, BSN, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Must be taking: Cabotegravir, Rilpivirine

Disqualifiers: Pregnancy, Incarceration, Moving, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 7

Duration: 15 months

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat HIV using long-acting injections of two drugs, cabotegravir and rilpivirine, for individuals living far from an HIV care provider. The study aims to determine if these injections are practical and well-received by both patients and healthcare staff, while also assessing their impact on factors like HIV stigma and medication adherence. It is suitable for people with HIV who live outside the Omaha, Nebraska area and are beginning this injection treatment as part of their regular HIV care. Participants will complete questionnaires and participate in an interview over 15 months, and clinic staff will also share their experiences. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for the CAB+RPV LA trial?

The trial information does not specify whether you need to stop your current medications. It's best to discuss this with your healthcare provider to understand how your current treatment might interact with the trial.

What prior data suggests that CAB+RPV LA is safe for people living with HIV?

Research shows that the combination treatment of cabotegravir and rilpivirine as long-acting injections (CAB+RPV LA) is generally safe for people with HIV. The most common side effects include reactions at the injection site, such as redness or swelling, which are usually mild and resolve on their own.

Studies have found that these injections are well-tolerated compared to standard oral treatments, with no major safety issues reported. Some participants have switched to CAB+RPV LA from other HIV treatments and found it equally effective and safe.

The FDA has already approved this treatment for HIV, providing extra reassurance about its safety. While every medication can have side effects, evidence so far suggests that CAB+RPV LA is safe for use in people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CAB+RPV LA for people with HIV because it offers a long-acting injectable option, which is a big shift from the traditional daily oral medications like tenofovir/emtricitabine-based therapies. This treatment combines cabotegravir (CAB) and rilpivirine (RPV) into an injectable form that only needs to be administered once every month or even every two months, reducing the pill burden and potentially improving adherence. Unlike the standard treatment regimens, which require daily intake, this approach aims to make it easier for patients to maintain their treatment schedule, especially those living in non-metropolitan areas with less frequent access to healthcare facilities.

What evidence suggests that CAB+RPV LA is effective for HIV?

Research shows that cabotegravir plus rilpivirine long-acting (CAB+RPV LA) injections effectively treat HIV. Studies have found that this treatment controls the virus as well as daily HIV pills. In this trial, participants receiving care at the University of Nebraska Medical Center (UNMC) Specialty Care Center who live outside the Omaha metropolitan area may choose to start CAB+RPV LA as part of their clinical care. Participants have reported high satisfaction with this treatment, noting it improves their experience compared to daily pills. The data indicates that the treatment is not only effective but also popular with patients, who experience fewer concerns about adherence and stigma. Overall, CAB+RPV LA offers a promising alternative to traditional daily HIV medications. ^{4 6 7 8 9}

Who Is on the Research Team?

Nada Fadul, MD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

Inclusion Criteria

Patient

I am 19 or older and have HIV.

I am receiving HIV care from a provider at Nebraska Medicine/UNMC SCC.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CAB+RPV LA injections as part of regular medical care for HIV, involving completing questionnaires and interviews

15 months

Monthly or every two months for injections

Follow-up

Participants are monitored for safety and effectiveness after treatment, including viral suppression and treatment satisfaction

15 months

Baseline, Month 7, and Month 15

What Are the Treatments Tested in This Trial?

Interventions

• Cabotegravir + Rilpivirine

How Is the Trial Designed?

Group I: Staff Experimental Treatment 6 Interventions

Staff at the University of Nebraska Medical Center (UNMC) Specialty Care Center or the Nebraska Medicine Grand Island clinic who provide HIV-related care and are involved in this study.

Group II: Participants Experimental Treatment 9 Interventions

Participants receiving care at the University of Nebraska Medical Center (UNMC) Specialty Care Center who live outside of the Omaha metropolitan area and who choose to start CAB+RPV LA as part of clinical care.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

ViiV Healthcare

Industry Sponsor

Trials

379

Recruited

479,000+

Founded

2009

Headquarters

London, England, UK

Known For

HIV Research

Top Products

- Tivicay (dolutegravir), - Triumeq (abacavir/dolutegravir/lamivudine), - Juluca (dolutegravir/rilpivirine), - Apretude (cabotegravir)

Dr. Harmony Garges

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration

Citations

1. academic.oup.com academic.oup.com/ofid/article/12/5/ofaf220/8116433

Clinical Outcomes and Perspectives of People With Human ... Participants receiving long-acting cabotegravir plus rilpivirine experienced high rates of virologic suppression and a low rate of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12339819/

Long-Term Real-World Use of Cabotegravir/Rilpivirine Despite increasing use of LA-CAB/RPV, long-term real-world data on durability, adherence, and virological outcomes remain limited to 2 years.

3. viivhealthcare.com viivhealthcare.com/hiv-news-and-media/news/press-releases/2025/july/long-acting-injectables-for-hiv-at-ias-2025/

ViiV Healthcare presents new data demonstrating positive ... 24-month outcomes of cabotegravir+rilpivirine long-acting every 2 months in a real‑world setting: effectiveness, adherence to injections, and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1341321X2500131X

Efficacy and safety of switching to long-acting cabotegravir ... Mean (SD) HIVTSQs treatment satisfaction scores of Japanese participants showed greater improvement from baseline to Month 12 in the CAB+RPV LA group (+6.25 [ ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40604367/

Patient-reported outcomes in clinical trials assessing the ... Results: Findings reveal that CAB + RPV-LA maintains high levels of viral suppression comparable to daily ART while improving patient ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12390647/

Safety, Tolerability, and Metabolic Effects of Long-Acting ... Clinical trial data suggest that LA CAB/RPV is generally safe and well tolerated. The most common side effects were injection site reactions, ...

7. academic.oup.com academic.oup.com/jac/article/80/3/624/7945415

Safety and efficacy of long-acting cabotegravir/rilpivirine ... This systematic review and meta-analysis compare the safety and efficacy of LAA versus standard oral treatment (SOT) for HIV.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03299049

NCT03299049 | Efficacy, Safety and Tolerability Study of ... This Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is designed to demonstrate the non-inferior antiviral activity and ...

9. aidsetc.org aidsetc.org/blog/hiv-meds-updates-long-acting-injectable-therapy-cabotegravir-rilpivirine

HIV Meds Updates - Long-acting Injectable Therapy At the International AIDS Society 2021 meeting, investigators presented week 124 efficacy and safety data on the CAB+RPV arm of the study.